Sun Pharma announced that the US Court of Appeals for the Federal Circuit affirmed the judgement of the US District Court for the Eastern District of Michigan against Eli Lily and Co finding certain claims of US Patent No. 5,464,826 (826 patent) invalid. The appeal arose out of a lawsuit that Eli Lilly filed against Sun Pharma in connection with Sun Pharma’s submission of an Abbreviated New Drug Application (ANDA) for a generic version of Gemzar.

In the Michigan lawsuit, Eli Lilly had contented that Sun Pharma’s ANDA infringed certain claims from the ’826 patent and US Patent No. 4,808,614 (614 patent) that describe gemcitabine and its uses, the active ingredient in Gemzar. Earlier the Michigan District Court had ruled against Eli Lily stating that the asserted claims of the ’826 patent are invalid for obviousness-type double patenting over US Patent No. 4,808,614 (“’614 patent”). The Appeals Court agreed with the ruling of the District Court, and noted that the Michigan Court had correctly followed the Federal Circuit’s precedent regarding double patenting. The ’826 patent, now ruled invalid, would have expired on November 7, 2012, and would have had paediatric exclusivity through May 7, 2013.

The ’614 patent, not part of the appeal, expired on May 15, 2010, but has paediatric exclusivity through November 15, 2010.

Gemzar is a registered trademark of Eli Lilly and Co.